Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Sterile Water for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: potential for trace amounts of product carryover.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
Affected NDC
0487-6105-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sterile Water NDC 00487-6105 |
WATER 1 mL/mL | Injection Intramuscular|intravenous|subcutaneous |
Nephron Pharmaceuticals Corporation | Rx |
- Recalling firm
- Nephron Sc Inc
- NDC code
- 0487-6105-01
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0178-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Nephron Sc Inc
All 2023 recalls
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
S2 Racepinephrine Inhalation Solution
Short Fill
Class II · Moderate risk
Other cgmp deviation recalls from 2023
All cgmp deviation recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Oxygen
cGMP Deviations
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.